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FDA reportedly will soon authorize updated COVID-19 boosters

The FDA is on the verge of authorizing updated COVID-19 boosters without the benefit of Phase 3 clinical trial data, according to media reports.

The bivalent boosters, based on the omicron sublineages BA.4 and BA.5 and the original form of SARS-CoV-2, could be available soon after Labor Day.

To authorize the omicron-specific COVID-COVID-19 boosters, FDA will likely review data from the first-generation mRNA COVID-19 vaccines, investigational omicron-specific boosters based on the BA.1 variant and preclinical research.

Moderna (Nasdaq:MRNA) is developing an updated COVID-19 vaccine, as are Pfizer (NYSE:PFE) and its partner BioNTech (Nasdaq:BNTX).

The agency hopes the boosters will offer a similar level of protection against SARS-CoV-2 that COVID-19 vaccines provided when they were first authorized in late 2020. At that point, the novel coronavirus had mutated relatively little, resulting in strong vaccine-induced immunity.

The emergence of m…

Using real-world evidence in clinical trials: Challenges and opportunities

Photo by Joshua Sortino on Unsplash

The healthcare industry traditionally has used site-based clinical trials to assess the efficacy and safety of drugs and medical devices. Data collected from participants in these trials would be evaluated to determine whether the product in question should be approved for commercial use.

In recent years, however, the exponential increase in patient data recorded by digital devices has raised the possibility that real-world data (RWD) and real-world evidence (RWE) may be used to augment clinical trial data.

But what are RWD and RWE? Are they the same thing? And how could they effectively be integrated into clinical trials to produce better outcomes for consumers?

Here’s how the FDA defines RWD and RWE:

Real-world data relate to patient health status and/or the delivery of healthcare routinely collected from a variety of sources. RWD can come from mul…

Genentech’s clinical supply center rethinks biologics manufacturing

Genentech CSC building exterior, South San Francisco, California [Image courtesy of Genentech]

Genentech has opened a novel clinical supply center at its birthplace in South San Francisco.

The planning for the new $250 million center began in 2019 when Genentech, a member of the Roche Group, began earnest efforts to imagine what the future of biomanufacturing looks like.

“We were looking at where we are going in the industry,” said Jeff Davis, the executive director of the Clinical Supply Center (CSC). “And what does Genentech need? What are the trends across the industry?”

One of those trends is prioritizing personalized medicines focused on small patient groups. Genentech thus determined it needed to supplement its large-volume manufacturing with more agile facilities. It began planning the construction of a fast, agile facility that can produce distinct batches on differe…

Medtronic implantable cardioverter defibrilator meets trial endpoints

Medtronic (NYSE:MDT) announced that its investigational EV ICD (implantable cardioverter defibrilator) system met trial endpoints.

The medtech giant designed its EV ICD system to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest (SCA). Medtronic’s device aims to avoid certain risks of traditional, transvenous ICDs as its lead (thin wire) is placed outside the heart and veins, under the breastbone (sternum) using a minimally invasive approach.

Placement in such a location aims to help avoid long-term complications that may be associated with leads in the heart and veins, including vessel occlusion and risks for blood infections.

Results from the Extravascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study were presented as late-breaking science at the European Society of Cardiology (ESC) Congress 2022 in Barcelona and simultaneously published in The New England Journal of Medicine, according to a news release…

CereVasc completes first eShunt procedure in U.S.

CereVasc announced today that it completed the first procedure with the eShunt device in the U.S. as part of a pilot study.

Boston-based CereVasc’s first eShunt procedure was completed as part of a U.S. pilot study of the system in normal pressure hydrocephalus (NPH) being conducted under FDA investigational device exemption (IDE). Approval for the trial came from the FDA in February.

Dr. Charles Matouk, associate professor of neurosurgery, vice chair of clinical affairs for neurosurgery and chief of neurovascular surgery at Yale Medicine, treated the patient.

“We are pleased to participate in this study of the eShunt System, a promising device with the potential to transform the care of patients with NPH using a minimally invasive approach as opposed to open surgery,” Matouk said in a news release.

CereVasc Chair and CEO Dan Levangie added: “This study, which will evaluate the safety and efficacy of the eShunt System, repr…

Medical device maker donates $3M worth of supplies to Ukraine

Medical device manufacturer V6CO today said it is sending nearly $3 million worth of medical supplies to Ukraine as Russia’s invasion stretches beyond six months.

New York City-based V6CO’s donation includes more than 11.5 million syringe sets in support of aid efforts.

“At V6CO we offer our support for the people who have been impacted by the invasion of Ukraine,” V6CO CEO Mance Zhu said in a news release. “As individuals and organizations, we can all do our part to collectively provide support and work to make a difference.”

Medical supplies remain in high demand in Ukraine as fighting continues and supply chains struggle to keep up, according to United Help Ukraine, the nonprofit charitable organization partnering with V6CO.

RELATED: Autotranfusion device maker ships units to Ukraine

“We remain grateful for the outpouring of support from dedicated groups across the globe in our fight to maintain …

Intera Oncology has a serious infusion pump recall

[Image from Intera Oncology’s webiste]The FDA issued a notice today declaring that the recall of an infusion pump from Intera Oncology is Class I, the most serious kind.

Intera recalled the Intera 3000 hepatic artery infusion pump after receiving reports from clinicians that the pumps were delivering medications (flow rate) faster than expected. If the pump delivers infusions at faster than expected flow rates, the patient may receive too much medication at one time, resulting in life-threatening hematologic (myelosuppression) toxicity, neurotoxicity or death.

Get the full story at our sister site, Drug Delivery Business News.

How pipette tips help support pharmaceutical R&D

[Image courtesy of Magdalena Wiklund on Flickr.]

Demand remains strong for instruments used for measuring liquid samples thanks in large part to strong demand across the healthcare sector. Pharmaceutical companies, diagnostics labs and academic institutions are notable consumers of liquid handling systems.

Pipette tips are a notable example of a liquid handling product observing growth demand. According to Future Market Insights, the pipette tips market is expected to register a CAGR of 8% by garnering a market value of $1.47 billion by the end of 2032. The use of the products in pharmaceutical R&D is a central driver of this growth.

Moreover, pipette tips’ ability to prevent cross-contamination during sample handling is increasing their use in the healthcare and pharmaceutical industries.

Technological advances along with the availability of standard, filtered and low-retention pipettes …

Galaxy Medical wins CE mark for pulsed electric field system for treating AFib

Galaxy Medical announced today that it received CE mark approval in Europe for its Centauri pulsed electric field (PEF) system.

San Carlos, California-based Galaxy Medical designed its Centauri system to target arrhythmias by delivering quick bursts of high-voltage, high-frequency energy for the treatment of paroxysmal AFib.

The company said in a news release that Centauri is the first commercially available system to enable PEF ablation with focal catheters which are used in the majority of cardiac ablation procedures worldwide.

“From the beginning, we designed Centauri to be the workhorse PEF system for all electrophysiology labs, enabling physicians to maintain use of their favored mapping systems and catheters,” Galaxy Medical CEO Dr. Jonathan Waldstreicher said in the release. “Our goal is to provide a safer and more effective alternative to thermal ablation for all practitioners of cardiac arrhythmia ablation, and the CE mark allo…

FDA clears Neuronetics’ motor threshold detection tech

Neuronetics (Nasdaq:STIM) announced today that it received FDA 510(k) clearance for its D-Tect MT accessory for the NeuroStar platform.

Malvern, Pennsylvania-based Neuronetics designed its D-Tect accessory to simplify the motor threshold (MT) determination for physicians.

According to a news release, the now FDA-cleared technology gives clinicians a way to determine MT by visually reporting the magnitude of finger movements during MT mapping for the treatment of major depressive disorder (MDD).

D-Tect also allows the MT determination to be performed by just one person, Neuronetics said. The company will make D-Tect available through a limited commercial launch initially, with a national rollout slated for mid-September. Practices will be trained on the product at NeuroStar University, which recently opened in Charlotte, North Carolina.

“The FDA clearance for the D-Tect MT Accessory is the next chapter in our plan to simplify and accelerate the MT …

Study says Abbott’s HeartMate3 heart pump extends survival by 5 years

The HeartMate 3 LVAD. [Image courtesy of LVAD]Abbott (NYSE:ABT) announced today that data demonstrates extended survival for advanced heart failure patients using HeartMate 3.

Data from the Momentum 3 trial — the world’s largest randomized clinical trial to assess long-term outcomes in people receiving a left ventricular assist device (also known as an LVAD or heart pump) to treat advanced heart failure — were presented during a late-breaking session at the 2022 European Society of Cardiology Congress in Barcelona, Spain.

The study demonstrated that HeartMate 3 extends the survival of advanced heart failure patients by at least five years, highlighting it as a life-saving option for people with later-stage disease.

According to a news release, Momentum 3 evaluated more than 1,000 patients and, for the first time in a clinical trial setting, found that people with advanced heart failure who received the HeartMate 3 heart pump lived beyond five years. T…

Össur acquires finger prosthetics company Naked Prosthetics

Össur (NSDQ:OSSR) announced today that it acquired Naked Prosthetics and its offerings for finger and partial hand amputees.

Hämeenlinna, Finland-based Össur’s acquisition of Naked Prosthetics, a developer of mechanical devices individually designed to mimic the natural motion of the finger, went into effect on Aug. 26, 2022.

The company said in a news release that its acquisition addresses a critical need for patients with finger and partial hand loss, adding to the Össur product portfolio while strengthening its limb product offerings around the globe. It also allows the company to address a broader group of amputees.

“Naked Prosthetics has developed functional and high-quality finger prostheses that complement our product portfolio and add an important range to our upper limb product offering,” said Össur President and CEO Sveinn Sölvason. “The acquisition strengthens our global market position, and we are pleased to welcome th…